Alcohol DrinkingNCT04219748
Effectiveness of a Case Management Intervention for Alcohol Use-Related Problems in Frequent Users of an Emergency Department
A study testing Case Management in people with Alcohol Drinking and Alcohol-Related Disorders, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Drinking, Alcohol-Related Disorders
- What is being tested?
- Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5 or more attendances during the previous 12 months at the Emergency Department of Hospital Clínic de Barcelona
- an AUDIT-C score higher than 5 points for men and 4 for women
- Patients who accept to participate in the study and give informed consent
- Exists valid contact information to reach patient in the future.
Who cannot join
- There is psychopathology that prevents study comprehension and/or future participation (i.e. cognitive impairment, acutely psychotic, acutely confused, intoxicated...)
- Patients who present medical conditions that predict that will not be able to participate in follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Case Management" de Problemes Per Ús d'Alcohol en Pacients Que Hiperfreqüenten el Servei d'Urgències
Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. To improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. Alcohol consumption is associated with a decrease in primary care services utilization, thus Emergency Departments (EDs) are a primary gateway to healthcare services in this group.
Depending on the investigative method and the mixture of the target population, an estimated 0.6-40% of all ED visits are due to alcohol-related problems. Given this, EDs offer a unique window of opportunity to address alcohol problems.
Read more
The threshold most commonly used to define frequent use of EDs is more than 4 visits per year. Frequent users comprise 0.3% to 10% of all ED patients and account for 3.5% to 28% of ED visits in developed countries. Addictive and other psychiatric disorders, and also social vulnerability are more common in frequent ED users than in non-frequent users. Although case management interventions seem promising to reduce ED attendance among frequent users, currently there is mixed evidence on the effects of such interventions on ED use.
Considering all this, a broader understanding of interventions to reduce frequent visits is needed, specially focusing on local frequent ED populations and identified highly vulnerable subgroups, such as hazardous drinkers.
The investigators aim to evaluate the effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital.
Read the detailed description
Methods:
Randomized controlled trial to evaluate the effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital in Barcelona. All patients between 18 and 65 years old that frequently attended Hospital Clínic of Barcelona emergency department during the previous year that reattend the ED during the recruitment period will be eligible to follow-up. Those of them presenting risky alcohol use according to AUDIT-C score will be randomized to either case management intervention or treatment as usual. Main outcomes will be the number of visits to the ED and proportion of risky drinkers measured by AUDIT-C at 3, 6, 9 and 12 months follow-up.
Case management (CM) can be defined as a collaborative process of assessment, planning, facilitation, and advocacy for options and services to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes. Case managers identify appropriate providers and services for individual patients while simultaneously ensuring that available resources are being used in a timely and cost-effective manner. It is a model of continuous, integrated medical and psychosocial care, which is markedly different from the episodic and often fragmented care that occurs in the ED setting. Close partnerships with healthcare providers and community services resources are key factors of CM interventions, that should target patients with the greatest needs.
- Conditions
- Alcohol Drinking, Alcohol-Related Disorders
- Being tested
- Case Management
- Keywords
- alcohol-related disorders, emergency department, frequent users, case management
- Medical subject headings
- Alcohol Drinking, Alcohol-Related Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagementBehavioural
Participants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team (Psychiatry, Social Work, Nursing) during 2 months. The intervention will encompass attending weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes.
This CM intervention will include referral to Hospital Clínic de Barcelona Addiction Outpatient Clinic and a personalised assessment of the medical, psychiatric and social situation of each individual by the CM team. An individualised care plan will be established and periodically reviewed by the multidisciplinary team in response to a better understanding of patient needs or to a change in patient health condition.
The intervention will offer motivational interviewing psychotherapy to enhance motivation to reduce or to quit alcohol use, in crisis intervention, coordination of care, patient education and self-management support, and assistance to navigate in the healthcare system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team during 2 months. They will attend weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes and will be conducted based on Motivational Interviewing techniques in order to explore values and needs and to enhance motivation to reduce alcohol use and self-efficacy.
Receiving the CM intervention doesn't exclude treatment as usual. Receives: Behavioral: Case Management |
| Control | No intervention | Only treatment as usual in the Emergency Department (and in the Health and Social Services Network). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency Department Visits
Measured: At 12 months after enrollment
Change from baseline in the proportion of risky drinkers measured by AUDIT-C
Participants will be assessed with AUDIT-C (a tool to assess alcohol consumption). Main outcome 2 is the proportion of patients who score more than 5 in men and more than 4 in women in this scale.
Measured: At baseline and at 3, 6, 9 and 12 months after enrollment
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable)
Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.
Measured: At baseline and at 3, 6, 9 and 12 months after enrollment
Secondary outcomes (3)
Change from baseline in quality of life according to EQ-5D-5L questionnaire
The EQ-5D-5L is a generic test to assess quality of life related to health. It includes 5 dimensions of quality of life (mobility, self-care, daily activities, pain, anxiety/depression) and a general evaluation of health status by a Visual Analogue Scale (VAS).
Measured: At baseline and at 3, 6, 9 and 12 months after enrollment
Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)
BPRS is a clinician rating scale that provides an assessment of common psychopathology symptoms. Minimum value: 18. Maximum value: 126. Higher scores indicate more severity of psychiatric symptoms.
Measured: At baseline and at 3, 6, 9 and 12 months after enrollment
Change from baseline in number of hospital admissions
Need of inpatient care
Measured: At baseline and at 3, 6, 9 and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start20 Jan 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Insufficient accrual rate to achieve expected sample size in the context of a global pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoni Gual, Hospital Clinic of Barcelona
- Investigators
- Antoni Gual, PhD, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219748
- Sponsor's protocol ID
- MALUA_Freq
- Other IDs
- HCB/2019/0717
- Status last verified
- May 2021
- First submitted
- 20 Dec 2019
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams S, Brown A, Patton R, Crawford MJ, Touquet R. The half-life of the 'teachable moment' for alcohol misusing patients in the emergency department. Drug Alcohol Depend. 2005 Feb 14;77(2):205-8. doi: 10.1016/j.drugalcdep.2004.07.011.
PubMed 15664722Vu F, Daeppen JB, Hugli O, Iglesias K, Stucki S, Paroz S, Canepa Allen M, Bodenmann P. Screening of mental health and substance users in frequent users of a general Swiss emergency department. BMC Emerg Med. 2015 Oct 9;15:27. doi: 10.1186/s12873-015-0053-2.
PubMed 26452550Simioni N, Rolland B, Cottencin O. Interventions for Increasing Alcohol Treatment Utilization Among Patients with Alcohol Use Disorders from Emergency Departments: A Systematic Review. J Subst Abuse Treat. 2015 Nov;58:6-15. doi: 10.1016/j.jsat.2015.06.003. Epub 2015 Jun 23.
PubMed 26206477Irving A, Goodacre S, Blake J, Allen D, Moore SC. Managing alcohol-related attendances in emergency care: can diversion to bespoke services lessen the burden? Emerg Med J. 2018 Feb;35(2):79-82. doi: 10.1136/emermed-2016-206451. Epub 2017 Nov 28.
PubMed 29183919Klein LR, Driver BE, Miner JR, Martel ML, Cole JB. Emergency department length of stay for ethanol intoxication encounters. Am J Emerg Med. 2018 Jul;36(7):1209-1214. doi: 10.1016/j.ajem.2017.12.017. Epub 2017 Dec 8.
PubMed 29305022Klein LR, Martel ML, Driver BE, Reing M, Cole JB. Emergency Department Frequent Users for Acute Alcohol Intoxication. West J Emerg Med. 2018 Mar;19(2):398-402. doi: 10.5811/westjem.2017.10.35052. Epub 2018 Feb 26.
PubMed 29560072Urbanoski K, Cheng J, Rehm J, Kurdyak P. Frequent use of emergency departments for mental and substance use disorders. Emerg Med J. 2018 Apr;35(4):220-225. doi: 10.1136/emermed-2015-205554. Epub 2018 Jan 8.
PubMed 29311114Verelst S, Moonen PJ, Desruelles D, Gillet JB. Emergency department visits due to alcohol intoxication: characteristics of patients and impact on the emergency room. Alcohol Alcohol. 2012 Jul-Aug;47(4):433-8. doi: 10.1093/alcalc/ags035. Epub 2012 Apr 5.
PubMed 22493048Anderson P, Berridge V, Conrod P, Dudley R, Hellman M, Lachenmeier D, Lingford-Hughes A, Miller D, Rehm J, Room R, Schmidt L, Sullivan R, Ysa T, Gual A. Reframing the science and policy of nicotine, illegal drugs and alcohol - conclusions of the ALICE RAP Project. F1000Res. 2017 Mar 17;6:289. doi: 10.12688/f1000research.10860.1. eCollection 2017.
PubMed 28435669Bruguera P, Barrio P, Oliveras C, Braddick F, Gavotti C, Bruguera C, Lopez-Pelayo H, Miquel L, Segura L, Colom J, Ortega L, Vieta E, Gual A. Effectiveness of a Specialized Brief Intervention for At-risk Drinkers in an Emergency Department: Short-term Results of a Randomized Controlled Trial. Acad Emerg Med. 2018 May;25(5):517-525. doi: 10.1111/acem.13384. Epub 2018 Apr 2.
PubMed 29418049Locker TE, Baston S, Mason SM, Nicholl J. Defining frequent use of an urban emergency department. Emerg Med J. 2007 Jun;24(6):398-401. doi: 10.1136/emj.2006.043844.
PubMed 17513534Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5.
PubMed 22221292LaCalle E, Rabin E. Frequent users of emergency departments: the myths, the data, and the policy implications. Ann Emerg Med. 2010 Jul;56(1):42-8. doi: 10.1016/j.annemergmed.2010.01.032. Epub 2010 Mar 26.
PubMed 20346540Meng X, Muggli T, Baetz M, D'Arcy C. Disordered lives: Life circumstances and clinical characteristics of very frequent users of emergency departments for primary mental health complaints. Psychiatry Res. 2017 Jun;252:9-15. doi: 10.1016/j.psychres.2017.02.044. Epub 2017 Feb 21.
PubMed 28237761Moschetti K, Iglesias K, Baggio S, Velonaki V, Hugli O, Burnand B, Daeppen JB, Wasserfallen JB, Bodenmann P. Health care costs of case management for frequent users of the emergency department: Hospital and insurance perspectives. PLoS One. 2018 Sep 24;13(9):e0199691. doi: 10.1371/journal.pone.0199691. eCollection 2018.
PubMed 30248102
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Case Management" de Problemes Per Ús d'Alcohol en Pacients Que Hiperfreqüenten el Servei d'Urgències
- ClinicalTrials.gov ID
- NCT04219748
- Acronym / sponsor ID
- MALUA_Freq
- Conditions
- Alcohol Drinking, Alcohol-Related Disorders
- Keywords
- alcohol-related disorders, emergency department, frequent users, case management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual rate to achieve expected sample size in the context of a global pandemic.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol use and its consequences represent an important public health problem. As well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. To improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. Alcohol consumption is associated with a decrease in primary care services utilization, thus Emergency Departments (EDs) are a primary gateway to healthcare services in this group.
Depending on the investigative method and the mixture of the target population, an estimated 0.6-40% of all ED visits are due to alcohol-related problems. Given this, EDs offer a unique window of opportunity to address alcohol problems.
The threshold most commonly used to define frequent use of EDs is more than 4 visits per year. Frequent users comprise 0.3% to 10% of all ED patients and account for 3.5% to 28% of ED visits in developed countries. Addictive and other psychiatric disorders, and also social vulnerability are more common in frequent ED users than in non-frequent users. Although case management interventions seem promising to reduce ED attendance among frequent users, currently there is mixed evidence on the effects of such interventions on ED use.
Considering all this, a broader understanding of interventions to reduce frequent visits is needed, specially focusing on local frequent ED populations and identified highly vulnerable subgroups, such as hazardous drinkers.
The investigators aim to evaluate the effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital.
Detailed description
Methods:
Randomized controlled trial to evaluate the effectiveness of a Case Management programme for ED Frequent Users presenting risky alcohol use in the ED of a tertiary hospital in Barcelona. All patients between 18 and 65 years old that frequently attended Hospital Clínic of Barcelona emergency department during the previous year that reattend the ED during the recruitment period will be eligible to follow-up. Those of them presenting risky alcohol use according to AUDIT-C score will be randomized to either case management intervention or treatment as usual. Main outcomes will be the number of visits to the ED and proportion of risky drinkers measured by AUDIT-C at 3, 6, 9 and 12 months follow-up.
Case management (CM) can be defined as a collaborative process of assessment, planning, facilitation, and advocacy for options and services to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes. Case managers identify appropriate providers and services for individual patients while simultaneously ensuring that available resources are being used in a timely and cost-effective manner. It is a model of continuous, integrated medical and psychosocial care, which is markedly different from the episodic and often fragmented care that occurs in the ED setting. Close partnerships with healthcare providers and community services resources are key factors of CM interventions, that should target patients with the greatest needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Case ManagementParticipants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team during 2 months. They will attend weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes and will be conducted based on Motivational Interviewing techniques in order to explore values and needs and to enhance motivation to reduce alcohol use and self-efficacy. Receiving the CM intervention doesn't exclude treatment as usual. |
| Control | No intervention | –Only treatment as usual in the Emergency Department (and in the Health and Social Services Network). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 5 or more attendances during the previous 12 months at the Emergency Department of Hospital Clínic de Barcelona
- an AUDIT-C score higher than 5 points for men and 4 for women
- Patients who accept to participate in the study and give informed consent
- Exists valid contact information to reach patient in the future.
Key exclusion criteria (2 listed)
- There is psychopathology that prevents study comprehension and/or future participation (i.e. cognitive impairment, acutely psychotic, acutely confused, intoxicated...)
- Patients who present medical conditions that predict that will not be able to participate in follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case ManagementParticipants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team (Psychiatry, Social Work, Nursing) during 2 months. The intervention will encompass attending weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes. This CM intervention will include referral to Hospital Clínic de Barcelona Addiction Outpatient Clinic and a personalised assessment of the medical, psychiatric and social situation of each individual by the CM team. An individualised care plan will be established and periodically reviewed by the multidisciplinary team in response to a better understanding of patient needs or to a change in patient health condition. The intervention will offer motivational interviewing psychotherapy to enhance motivation to reduce or to quit alcohol use, in crisis intervention, coordination of care, patient education and self-management support, and assistance to navigate in the healthcare system. | Behavioural | Intervention |
Primary outcome
Number of Emergency Department Visits
Time frame: At 12 months after enrollment
Change from baseline in the proportion of risky drinkers measured by AUDIT-C
Time frame: At baseline and at 3, 6, 9 and 12 months after enrollment
Participants will be assessed with AUDIT-C (a tool to assess alcohol consumption). Main outcome 2 is the proportion of patients who score more than 5 in men and more than 4 in women in this scale.
Change from baseline in the severity of alcohol use according to AUDIT (Alcohol Use Disorders Identification Test) score (as a continuous variable)
Time frame: At baseline and at 3, 6, 9 and 12 months after enrollment
Minimum value: 0. Maximum value: 40. Higher scores indicate more severity of alcohol use.
3 secondary outcomes
Change from baseline in quality of life according to EQ-5D-5L questionnaire
Time frame: At baseline and at 3, 6, 9 and 12 months after enrollment
Change from baseline in psychiatric symptoms severity through Brief Psychiatric Rating Scale (BPRS)
Time frame: At baseline and at 3, 6, 9 and 12 months after enrollment
Change from baseline in number of hospital admissions
Time frame: At baseline and at 3, 6, 9 and 12 months after enrollment
Results and safety
The study was stopped early (reason given: Insufficient accrual rate to achieve expected sample size in the context of a global pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Background: PubMed 15664722Williams S, Brown A, Patton R, Crawford MJ, Touquet R. The half-life of the 'teachable moment' for alcohol misusing patients in the emergency department. Drug Alcohol Depend. 2005 Feb 14;77(2):205-8. doi: 10.1016/j.drugalcdep.2004.07.011.
- Background: PubMed 26452550Vu F, Daeppen JB, Hugli O, Iglesias K, Stucki S, Paroz S, Canepa Allen M, Bodenmann P. Screening of mental health and substance users in frequent users of a general Swiss emergency department. BMC Emerg Med. 2015 Oct 9;15:27. doi: 10.1186/s12873-015-0053-2.
- Background: PubMed 26206477Simioni N, Rolland B, Cottencin O. Interventions for Increasing Alcohol Treatment Utilization Among Patients with Alcohol Use Disorders from Emergency Departments: A Systematic Review. J Subst Abuse Treat. 2015 Nov;58:6-15. doi: 10.1016/j.jsat.2015.06.003. Epub 2015 Jun 23.
- Background: PubMed 29183919Irving A, Goodacre S, Blake J, Allen D, Moore SC. Managing alcohol-related attendances in emergency care: can diversion to bespoke services lessen the burden? Emerg Med J. 2018 Feb;35(2):79-82. doi: 10.1136/emermed-2016-206451. Epub 2017 Nov 28.
- Background: PubMed 29305022Klein LR, Driver BE, Miner JR, Martel ML, Cole JB. Emergency department length of stay for ethanol intoxication encounters. Am J Emerg Med. 2018 Jul;36(7):1209-1214. doi: 10.1016/j.ajem.2017.12.017. Epub 2017 Dec 8.
- Background: PubMed 29560072Klein LR, Martel ML, Driver BE, Reing M, Cole JB. Emergency Department Frequent Users for Acute Alcohol Intoxication. West J Emerg Med. 2018 Mar;19(2):398-402. doi: 10.5811/westjem.2017.10.35052. Epub 2018 Feb 26.
- Background: PubMed 29311114Urbanoski K, Cheng J, Rehm J, Kurdyak P. Frequent use of emergency departments for mental and substance use disorders. Emerg Med J. 2018 Apr;35(4):220-225. doi: 10.1136/emermed-2015-205554. Epub 2018 Jan 8.
- Background: PubMed 22493048Verelst S, Moonen PJ, Desruelles D, Gillet JB. Emergency department visits due to alcohol intoxication: characteristics of patients and impact on the emergency room. Alcohol Alcohol. 2012 Jul-Aug;47(4):433-8. doi: 10.1093/alcalc/ags035. Epub 2012 Apr 5.
- Background: PubMed 28435669Anderson P, Berridge V, Conrod P, Dudley R, Hellman M, Lachenmeier D, Lingford-Hughes A, Miller D, Rehm J, Room R, Schmidt L, Sullivan R, Ysa T, Gual A. Reframing the science and policy of nicotine, illegal drugs and alcohol - conclusions of the ALICE RAP Project. F1000Res. 2017 Mar 17;6:289. doi: 10.12688/f1000research.10860.1. eCollection 2017.
- Background: PubMed 29418049Bruguera P, Barrio P, Oliveras C, Braddick F, Gavotti C, Bruguera C, Lopez-Pelayo H, Miquel L, Segura L, Colom J, Ortega L, Vieta E, Gual A. Effectiveness of a Specialized Brief Intervention for At-risk Drinkers in an Emergency Department: Short-term Results of a Randomized Controlled Trial. Acad Emerg Med. 2018 May;25(5):517-525. doi: 10.1111/acem.13384. Epub 2018 Apr 2.
- Background: PubMed 17513534Locker TE, Baston S, Mason SM, Nicholl J. Defining frequent use of an urban emergency department. Emerg Med J. 2007 Jun;24(6):398-401. doi: 10.1136/emj.2006.043844.
- Background: PubMed 22221292Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Gual, PhD, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management in people with Alcohol Drinking and Alcohol-Related Disorders, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual rate to achieve expected sample size in the context of a global pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Emergency Department Visits (time frame: At 12 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219748, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.